A Water for injection, sterile CEP of the European Pharmacopoeia monograph is often referred to as a Water for injection, sterile Certificate of Suitability (COS). The purpose of a Water for injection, sterile CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Water for injection, sterile EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Water for injection, sterile to their clients by showing that a Water for injection, sterile CEP has been issued for it. The manufacturer submits a Water for injection, sterile CEP (COS) as part of the market authorization procedure, and it takes on the role of a Water for injection, sterile CEP holder for the record. Additionally, the data presented in the Water for injection, sterile CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Water for injection, sterile DMF.
A Water for injection, sterile CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Water for injection, sterile CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Water for injection, sterile suppliers with CEP (COS) on PharmaCompass.